23andMe to work with FDA for approval

23andMe, the health and ancestry startup, is slowly but surely moving along in the U.S. Food and Drug Administration’s regulatory review process to sell a medical device.

The FDA recently agreed to review 23andMe’s submission for a health report focused on Bloom syndrome, a rare condition that could result in death by the mid-20s. The review process typically takes around 90 days, but the report is part of the FDA’s regulatory review of 23andMe’s health product.

Last November, the FDA sent a warning letter to 23andMe, ordering it to stop marketing its saliva collection kits for its personal genome service.

There were, and are, two big issues: 23andMe is selling a medical device that is intended to diagnose diseases without approval from the FDA; and the company has failed to prove that it has clinically validated its personal genome service.